Manufacturing Specialist

SpectronRx; Bunker Hill (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

SpectronRx, a growing CDMO with locations in Indianapolis, IN and other sites, seeks a Manufacturing Specialist to perform process manufacturing of radiopharmaceutical products and to prepare production materials. You will help maintain production equipment and ensure GMP compliance.

The role emphasizes accurate data handling, attention to detail, and collaboration with a multidisciplinary team, with minimal travel and physical requirements such as lifting up to 50 pounds and standing for

Qualifications

• HS diploma or equivalent required.
• Excellent communication, analytical, computer/PC and technical writing skills.
• Ability to work in a fast-paced manufacturing environment and in a team.
• Attention to detail and strong organizational skills are essential.

Responsibilities

• Carry out production responsibilities to meet schedules.
• Perform chemistry manipulations in a GMP environment.
• Ensure regulatory compliance of production protocols.
• Prepare and submit required reports; support deviation reports, OOS, CAPA.
• Assist with creating SOPs and maintenance of production equipment.
• Assist with waste management and general lab cleanliness.

Skills

Communication

Analytical

Computer skills

Technical writing

Attention to detail

Organizational skills

Time management

Teamwork

Basic math

Education

HS diploma or equivalent

Associates degree in chemistry or related field

Job description

SpectronRx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana production locations in South Bend, IN; Bunker Hill, IN; and Danbury, CT. We are seeking an experienced Manufacturing Specialist to join our growing company. The Manufacturing Specialist will be responsible for process manufacturing of radiopharmaceutical products, preparation of production materials, supplies, and general production equipment maintenance.

ESSENTIAL FUNCTIONS

• Carries out production responsibilities to meet manufacturing schedules.
• Performs chemistry manipulations for production in a GMP environment.
• Ensure regulatory compliance of production protocols within the manufacturing operations.
• Prepare and submit required reports.
• Supporting and executing deviation reports, OOS, root cause investigations and CAPA.
• Optimize and validate methods and procedures for radiopharmaceutical products.
• Assist with creating SOPs for use in production.
• Assist with general lab cleaning, supplies and maintenance.
• Assist with waste management.
• Performs other related duties as assigned.
• Physical Ability – Must be able to lift up to 50 pounds at a time and stand for prolonged periods.
• Attention to Detail – Ability to accurately count, verify, and record data.
• Active Listening – Giving full attention to instructions and communications, asking questions as appropriate.
• Speaking – Talking to others to convey information effectively.
• Time Management – Managing own time to prioritize tasks and meet deadlines.
• Coordination – Adjusting actions in relation to others’ actions in a team environment.
• Oral Comprehension – The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Written Comprehension – The ability to read and understand information and ideas presented in writing.
• Basic Math Skills – Ability to count accurately and perform basic arithmetic for reconciliation.
• Organizational Skills – Ability to maintain orderly areas and accurate records.

TRAVEL

• Regular travel is minimal.

REQUIRED EDUCATION AND EXPERIENCE

• HS diploma or equivalent or 2 years of academic or work experience.
• Excellent communication, analytical, computer/PC and technical writing skills.
• The ability to handle responsibilities in a fast-paced manufacturing environment.
• Demonstrated ability to work as part of a team.
• Excellent organizational skills and attention to detail.

PREFERRED EDUCATION AND EXPERIENCE

• An associates degree in chemistry, biochemistry, chemical engineering, or a related field preferred.
• Aseptic processing experience preferred.
• Prior experience in pharmaceuticals, preferably in a quality or production position, is ideal.
• Prior experience in a radiopharmaceutical environment is a plus.
• Good communication, analytical, computer/PC and technical writing skills.
• Ability to train and be trained.

ADDITIONAL REQUIREMENTS

• Pass a Background Check.
• Prolonged periods of standing, walking, bending, and lifting.

ADDITIONAL INFORMATION/BENEFITS

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
• We recognize that people come with a wealth of experience and talent beyond just the technical requirements of the job. If your experience doesn’t match what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodation during the interview process.
• We are an equal opportunity employer. Qualified applicants shall be considered for all positions without regard to race, color, sex, religion, national origin, age, disability, veteran status, or any other status protected by federal, state or local law. Refusal to submit to testing will result in disqualification of further employment consideration.